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Chemoradiotherapy of NSCLC Stage IIIB

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pierre Fabre Laboratories
Ligue contre le cancer, France
Information provided by:
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00198432
First received: September 13, 2005
Last updated: December 23, 2005
Last verified: December 2005
History of Changes
  Purpose

To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.


Condition Intervention Phase
NSCLC Stage IIIB
Concomitant Radiochemotherapy
 Drug: Paclitaxel, vinorelbine, cisplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Objective response rate

Secondary Outcome Measures:
  • Overall survival
  • Time to progression
  • Relapse rate (local control)
  • Safety

Estimated Enrollment: 130
Study Start Date: March 2002
Estimated Study Completion Date: December 2006
Detailed Description:

Chemotherapy:

C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²

Radiotherapy:

66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (>= 9MV)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural
  • PS = 0 or 1
  • Possibility of including all the targets in only one exposure field
  • Slimming < 10% of the weight of the body
  • Functions hepatic, renal and hematologic normal
  • VEMS >40% and PaO2 >60 mmHg
  • written and signed informed consent

Exclusion criteria :

- NSCLC stage IV or wet-IIIB

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198432

Locations
France
CHU Saint-Etienne Pneumologie
Saint-Etienne, France, 42000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Bristol-Myers Squibb
Pierre Fabre Laboratories
Ligue contre le cancer, France
Investigators
Principal Investigator: Pierre Fournel, Dr IFCT
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00198432     History of Changes
Other Study ID Numbers: IFCT-0201
Study First Received: September 13, 2005
Last Updated: December 23, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin
 Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 13, 2013